Pilot and Feasibility Study of a Mirrors Intervention for Reducing Delirium in Older Cardiac Surgical Patients

Overview

This pilot cluster-randomised controlled trial aims to determine whether the use of bedside mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium and improve outcomes in the older cardiac surgical patient.

Full Title of Study: “Can an Evidence-based Mirrors Intervention Reduce Postoperative Delirium in Older Cardiac Surgical Patients? A Pilot and Feasibility Cluster Randomised Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2013

Detailed Description

The risk of delirium, an acute disturbance in mental status and cognition that occurs commonly after cardiac surgery, increases sharply from the age of about 65 years. Its occurrence, even for one day, is associated with longer ICU and hospital stays, increased costs, and negative physical and cognitive outcomes at one year. In spite of previous prevention and intervention research, delirium incidence in the older cardiac surgical patient remains high (up to 72%). ICU clinicians at Papworth Hospital have made observations suggesting that delirium could be reduced using a novel and unconventional strategy of bedside mirrors. Mirrors of any type are uncommon in ICU environments[1], but their occasional use by patients on our ICU has been reported by bedside clinicians and physiotherapists to result in: – a normalisation of mental status and attention (core delirium diagnostic criteria), and – earlier physical mobilisation (associated with reduced delirium risk), particularly in older-aged patients Evidence from other sources supports mirrors' beneficial effect in these areas [2-10], but mirror use has never to our knowledge been explored for the reduction of delirium. This pilot study seeks to determine whether the use of bedside mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium and improve outcomes in the older cardiac surgical patient.

Interventions

  • Other: Mirrors Intervention
    • Coaching in the use of two types of mirrors to support mental status and attention, physical mobility, and sense of body awareness and ownership, as well as patient dignity and privacy in self-care. To be administered at set times and in a standardised way by ICU nursing and physical therapy teams.

Arms, Groups and Cohorts

  • Experimental: Mirrors Intervention
    • Patients allocated to Mirrors will receive a structured, protocol-driven bedside mirrors intervention as part of their postsurgical ICU care. This intervention will commence as soon as all anaesthetic agents have been switched off and the patient is awake following surgery unless considered clinically inappropriate.
  • No Intervention: Standard Care
    • Patients allocated to Standard Care will receive the usual postsurgical ICU care that does not include the use of mirrors.

Clinical Trial Outcome Measures

Primary Measures

  • Delirium incidence
    • Time Frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
    • Delirium will be measured twice daily, using the Confusion Assessment Method for the ICU (CAM-ICU).

Secondary Measures

  • Delirium time of onset
    • Time Frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
    • This is the patient’s first occurrence of delirium, as measured using the CAM-ICU, counted in number of days from admission to ICU.
  • Delirium duration
    • Time Frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
    • This is the total number of ICU days with delirium, as measured using the CAM-ICU
  • Mental Status
    • Time Frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
    • Measured from Features 1 & 3 of CAM-ICU
  • Attention
    • Time Frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
    • Measured from Feature 2 of CAM-ICU
  • Functional Independence
    • Time Frame: Assessed at 12 weeks after surgery
    • Measured using Barthel Index
  • Perceptual disturbances about the body and dissociative symptoms
    • Time Frame: Assessed at 12 weeks after surgery
    • Measured using interview described in previous work (Morgan et al., Biol Psychiatry, 2011)
  • Health-Related Quality of Life (HRQoL)
    • Time Frame: Assessed at 12 weeks after surgery
    • Measured using EQ-5D
  • Length of ICU and hospital stay
    • Time Frame: Assessed at hospital hospital discharge
    • This is the patient’s length of stay in ICU and hospital, in number of days from admission date until discharge date.
  • Mortality
    • Time Frame: Assessed at 12 weeks after surgery
    • This is patient mortality from admission to ICU until 12 weeks after surgery.
  • Factual memories from ICU
    • Time Frame: Assessed at 12 weeks after surgery
    • Measured using the ICU Memory Tool (Jones et al., Clin Intensive Care, 2000)
  • Intraclass correlation coefficient (ICC) for time clusters
    • Time Frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
    • This is a measure of the within-cluster correlation necessary for calculating sample size necessary for a definitive trial if warranted
  • Acceptability of the intervention
    • Time Frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
    • This is the number of instances when the intervention was considered appropriate by clinicians and accepted and used by patients, divided by total recorded indicated instances.

Participating in This Clinical Trial

Inclusion Criteria

  • scheduled for elective or urgent cardiac surgery at Papworth Hospital – aged 70+ years Exclusion Criteria:

  • inability to obtain informed consent – care pathway anticipating admission elsewhere than to ICU following surgery – severe visual impairment impeding ability to recognise self in mirror – physical or communication barriers likely to impede effective administration of study procedures – severe mental disability likely to impede effective administration of study procedures or assessment of delirium – history of psychiatric illness previously requiring hospitalisation

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Papworth Hospital NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Alain Vuylsteke, MD, Principal Investigator, Papworth Hospital NHS Foundation Trust

References

Freysteinson WM. The use of mirrors in critical care nursing. Crit Care Nurs Q. 2009 Apr-Jun;32(2):89-93. doi: 10.1097/CNQ.0b013e3181a27b3d.

Vanhaudenhuyse A, Schnakers C, Bredart S, Laureys S. Assessment of visual pursuit in post-comatose states: use a mirror. J Neurol Neurosurg Psychiatry. 2008 Feb;79(2):223. doi: 10.1136/jnnp.2007.121624. No abstract available.

Tabak N, Bergman R, Alpert R. The mirror as a therapeutic tool for patients with dementia. Int J Nurs Pract. 1996 Sep;2(3):155-9. doi: 10.1111/j.1440-172x.1996.tb00042.x.

Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available.

Tung ML, Murphy IC, Griffin SC, Alphonso AL, Hussey-Anderson L, Hughes KE, Weeks SR, Merritt V, Yetto JM, Pasquina PF, Tsao JW. Observation of limb movements reduces phantom limb pain in bilateral amputees. Ann Clin Transl Neurol. 2014 Sep;1(9):633-8. doi: 10.1002/acn3.89. Epub 2014 Sep 30.

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